CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
Piperaquine (low dose) +5 moredrug
Likely dose
Piperaquine (low dose) 480 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03454048
NCT03454048N/ACompleted
CompareCT.gov

Controlled Human Malaria Infection Study to Assess Gametocytemia and Mosquito Transmissibility in Participants Challenged With Plasmodium Falciparum by Sporozoite or Blood Stage Challenge to Establish a Model for the Evaluation of Transmission-blocking Interventions

Radboud University Medical Center·interventional·Posted Mar 5, 2018·Updated Jul 7, 2020

In Brief

A clinical study evaluating Piperaquine (low dose), Piperaquine (high dose), and 4 other interventions for Malaria,Falciparum and 3 related conditions. Completed, enrolled 24 participants across 1 site.

Detailed Summary

This is a single-center, open label study. The primary aim of this project is to develop a controlled human malaria infection transmission model ("CHMI-trans") or "challenge model" to evaluate the capacity of vaccines, biologics (monoclonal antibodies, or mAbs), and drugs to block malaria parasite transmission by assessing infectiousness of Plasmodium falciparum (Pf) gametocyte carriers for Anopheles mosquitoes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria,Falciparum, Gametocytes, Controlled Human Malaria Infection, Transmission
CountriesNetherlands
CollaboratorsThe PATH Malaria Vaccine Initiative (MVI), QIMR Berghofer Medical Research Institute

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMar 5, 2018
Enrollment StartMay 7, 2018
Primary CompletionNov 1, 2018
Study CompletionNov 20, 2018
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 8.3 years ago

Interventions

Piperaquine (low dose)drug

subcurative regimen (480 mg)

Piperaquine (high dose)drug

Curative regimen (960mg)

Sulfadoxine pyrimethaminedrug

Curative regimen (1000mg/50mg)

Atovaquone Proguanildrug

Curative regimen (1000/400 mg, for 3 days)

malaria challenge infection, P. falciparum 3D7other

malaria challenge infection by P. falciparum 3D7-infected mosquito bites

Blood stage malaria challenge infection, P. falciparum 3D7other

P. falciparum 3D7-infected human erythrocytes administered intravenously for the purpose controlled human malaria infection.